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Medtronic FDA Approvals

0 new drug approvals and 12 device clearances on file. Matched by name to MDT.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Trexon™ Monofilament Synthetic Absorbable Suture510(k)May 28, 2026General, Plastic Surgery
Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter510(k)Jan 16, 2026Cardiovascular
Sphere-9Dx Diagnostic Catheter (AFR-00009)510(k)Aug 7, 2024Cardiovascular
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated510(k)Feb 23, 2024Cardiovascular
CD Horizon Spinal System510(k)Jan 23, 2023Orthopedic
SelectSite C304 Deflectable Catheter System, C315 Delivery System510(k)Nov 8, 2022Cardiovascular
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system510(k)Nov 7, 2022Cardiovascular
CD Horizon™ Spinal System510(k)May 25, 2022Orthopedic
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System510(k)Sep 16, 2021Cardiovascular
CD Horizon Spinal System510(k)Jun 23, 2021Neurology
CD Horizon™ Spinal System510(k)Apr 30, 2021Orthopedic
Infinity™ OCT System, PASS OCT® Spinal System510(k)Mar 18, 2021Orthopedic

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